Event Notification Report for January 19, 2017

AGREEMENT STATE REPORT - RECEIVED DOSE LESS THAN PRESCRIBED DOSE

The following is excerpted from an email:

"On January 20, 2017 the licensee informed the Department [Pennsylvania Department of Environmental Protection Bureau of Radiation Protection] of an under dose incident involving yttrium-90 (Y-90) TheraSpheres. It is reportable as per 10 CFR 35.3045(a)(1)(i).

"On January 19, 2017 a patient underwent a Y-90 TheraSphere treatment. The staff reported the procedure went as planned; however, upon surveying the waste and performing a dose calculation it was found that the patient received approximately 29% of the prescribed dose. The patient was notified of this under dose on January 20, 2017. The physician utilized contrast medium to view the flow prior to the procedure and no issues were seen. No increased resistance was noted and the physician was able to flush the line post administration. The manufacturer was notified and will be conducting a joint investigation with the hospital staff. No harm is expected to the patient.

"A reactive inspection is planned by the Department. More information will be provided upon receipt.

"PA Event Report ID No: PA 170001"

A Medical Event may indicate potential problems in a medical facility's use of radioactive materials. It does not necessarily result in harm to the patient.

AGREEMENT STATE REPORT - INCORRECT DRUG DELIVERED TO PATIENT

The following was received via E-mail:

"The North Carolina Radioactive Materials Branch (RMB) is submitting a report of a possible Medical Event reportable under 10 CFR 35.3045(a)(2)(i). Specifically, a dose was delivered to a patient with an effective dose equivalent (50 rem) to an organ through the administration of a wrong radioactive drug containing byproduct material. The RMB received the report of the possible Medical Event on 1/19/2017.

"NC Licensee Duke University, License 0247-4, reported to the RMB that around 1300 EST on 1/19/2017 a patient scheduled for a thyroid uptake scan in the Diagnostic Nuclear Medicine Department was incorrectly identified and received an oral dose of 2.0 mCi of Iodine-123 instead of the intended dose of 5-12 microCi of Iodine-131.

"An investigation was held on 1/20/2017 with members of Duke University to include the individual that delivered the incorrect dose to the patient. Following a review of the licensee's current procedures, it was noted that there is a minimum of two methods of patient verification prior to the administration of any diagnostic radioactive drug to any patient. An interview was conducted with the CNMT [Certified Nuclear Medicine Technologist] that delivered the incorrect dose and they freely admitted to not following the proper protocol which consists of confirming the Name and Date of Birth of the patient. Other factors may have attributed to this misadministration to include the volume of patients being treated that day and that there were two patients present that day with very similar first and last names. The patient with the similar name received the proper dose for their procedure.

"Following interviews with Duke personnel, it was determined that the CNMT received the proper training to adhere to this two factor authentication as dictated by internal procedures and was authorized under an approved AU for such uses. At this time, it appears the cause for this misadministration is due to human error.

"This investigation is ongoing and more details are to follow to update this report. Several records were requested of the licensee to include a dose assessment to verify the EDE of 50 rem or any excess of 50 rem delivered to the organ. The licensee is compiling it's 15 Day Report and will be providing it to the RMB as required by the Rule. Following receipt of that report, this event will be updated."

A Medical Event may indicate potential problems in a medical facility's use of radioactive materials. It does not necessarily result in harm to the patient.

AGREEMENT STATE REPORT - SHUTTER STUCK CLOSED ON FIXED NUCLEAR GAUGE

The following information was provided by the State of Texas via email:

"On January 19, 2017, the Agency [Texas Department of State Health Services] was notified by the licensee's radiation safety officer (RSO) that the shutter on a Ronan model SA1-F37 gauge, S/N 5432GK containing a 50 millicurie cesium - 137 source would not open during an inspection. The RSO stated the gauge does not create an exposure risk to their employees or any member of the general public. The RSO stated a service provider has been contacted to repair the gauge. Additional information will be provided in accordance with SA-300.

"Texas Incident #: I-9459"